Abstract: Conventional glucometer systems for plasma/blood glucose monitoring are based on colorimetry or static electrochemistry using a fixed input signal. The recent glucometer Linus, Wellion, Agamatrix, USA, based on wavesense dynamic electrochemistry, uses a time-varying input signal to give a more accurate glucose reading. The purpose of this study was to compare the plasma glucose (PG) readings obtained by nursing staff from glucometer Linus and PG values estimated on an approved analyzer Daytonaâ¢, Randox, Global Medical Instrumentation, Inc., MN, USA. In the course of 5 weeks, 221 fingerprick capillary blood samples were taken from persons with diabetes at different times and investigated using glucometer Linus. Within two following minutes, blood from the same fingerprick was also collected in a tube and centrifuged; the plasma was analyzed on the Daytona⢠analyzer. Statistical analysis was performed using the software SPSS v. 15.0, SPSS Inc., Chicago, IL, USA. A total of 221 paired PG values were plotted on the error grid diagram indicating that 218 values (98.6%) of the glucose readings (Linus vs. Daytona) were within the clinically accurate zone A (maximum difference ±20%) and 3 values (1.4%) within the acceptable zone B. Daytona showed 4 PG values <4.2 mmol/l (75 mg/dl) and their difference of respective Linus readings was always <0.83 mmol/l (15 mg/dl). Correlation of results was strong (r = 0.992). Glucometer Linus readings correspond to the ISO and FDA standards. So, Linus appears to be an accurate device for PG-self-monitoring and clinical practice.
Abstract: BACKGROUND: The glycemic index (GI) is routinely measured 120 minutes after food intake (GI120). The purpose of this prospective open label study was to assess (1) the dynamics of glycemia over the 210 minutes following food consumption and (2) the evolution of GIs based on 120-, 150-, 180-, and 210-minute glycemic profiles. METHOD: Twenty healthy subjects (mean +/- SE; 21.9 +/- 1.39 years of age; body mass index 23.6 +/- 0.63 kg/m(2); 7 men and 13 women) completed the study. Each subject consumed 10 different foods with known GI120 on three separate occasions at four different times of day according to a defined meal plan over a 9-day period; 32 meals were evaluated. The GIs for intervals of 120, 150, 180 and 210 minutes after food consumption were determined using a continuous glucose monitoring system (CGMS) to measure glycemia. The Wilcoxon signed-rank test was applied to compare the GIs. RESULTS: Glycemia returned to baseline within 120 minutes for honey and tomato soup; within 210 minutes for white bread, choco-rice cookies, fish and potatoes, wafers, and meat ravioli with cheese; and later for dark chocolate, apricot dumplings, and choco-wheat cookies. The extended GIs were higher than the respective GI120s in eight of the foods. CONCLUSIONS: The 120-minute glycemic index fails to fully account for changes in glycemia after ingestion of a mixed meal because glycemia remains above baseline for a longer period. The CGMS is a convenient method to determine the glucose response/GIs over intervals extended up to 210 minutes, which is adequate time for the absorption of most foods.
Abstract: The purpose of this prospective open-label trial was (1) to assess the influence of oral antidiabetic drugs (OAD) on the glycemic index (GI), glucose response curves (GRCs), daily mean plasma glucose (MPG) and (2) to compare the GI of foods in persons with OAD-treated type 2 diabetes mellitus (T2DM) with the respective GI in healthy persons (HP).
Abstract: BACKGROUND: Conducted by highly experienced investigators with abundant time and resources, phase III studies of continuous glucose sensing (CGS) may lack generalizability to everyday clinical practice. METHOD: Community or academic practices in six Central and Eastern European or Mediterranean countries prospectively established an anonymized registry of consecutive patients with type 1 insulin-dependent diabetes mellitus starting CGS-augmented insulin pump therapy with the Paradigm((R)) X22 (Medtronic MiniMed, Northridge, CA) under everyday conditions, without prior CGS with another device. We compared glycosylated hemoglobin (GHb) values before and after 3 months of CGS and assessed relationships between insulin therapy variables and glycemia-related variables at weeks 1, 4, and 12 of CGS. Results: Of 102 enrolled patients, 85 (83%) with complete weeks 1, 4, and 12 sensor data and baseline/3-month GHb data were evaluable. Evaluable patients were approximately 54% male and approximately 75% adult (mean age, 33.2 +/- 16.9 years) with longstanding diabetes and high personal/family education levels. Mean GHb declined significantly after 3 months of CGS (7.55 +/- 1.33% at baseline to 6.81 +/- 1.08% after 12 weeks, 0.74% absolute decrease, P < 0.001). The absolute GHb reduction correlated significantly (P < 0.0005) with baseline GHb: larger absolute reductions tended to occur when baseline levels were higher. An increased basal insulin dose as a percentage of the total daily insulin dose and a decreased daily bolus count from week 1 to week 12 of CGS predicted GHb improvement from baseline to week 12. CONCLUSIONS: CGS-augmented insulin pump therapy appears to improve glycemic control in type 1 diabetes in varied everyday practice settings.
Abstract: BACKGROUND: The latest Paradigm 722 insulin pump, Medtronic MiniMed, USA, enables daily reading of 288 interstitial fluid glucose concentrations determined by a sensor inserted into subcutaneous tissue; the sensor signals are transmitted into the insulin pump, enabling the patient to see real-time glucose concentration on the display and adapt further treatment. AIMS: To assess the evolution of HbA1c over the course of a 3-month period in two cohorts of persons with type 1 (n=39) or type 2 (n=3) diabetes (PWD): 1) PWD on Paradigm 722 using sensors for continuous glucose monitoring (CGM group), 2) PWD on other types of insulin pumps performing intensive self-monitoring as before (3 to 6 times/d) on glucometer Linus, Wellion, Agamatrix (control group). METHODS: Compliant PWDs using insulin pump with insulin aspart for several previous months were included in the study. Seventeen were put on Paradigm 722 with CGM and 25 were included in the control group. Paired t-test and the statistical program SPSS v.15.0 were used to analyze the data. RESULTS: There was no significant difference in age between the two groups (P=0.996), in diabetes duration (P=0.482) or in daily insulin dose (P=0.469). In the CGM group (but not in the control group) HbA1c/IFCC dropped from 6.98+/-0.43 % to 5.98+/-0.36 % (P=0.006) within 1 month and remained reduced. CONCLUSION: The use of the Paradigm 722 insulin pump with CGM resulted in significant improvement in HbA1c which appeared within one month and remained throughout the whole 3-month study period. No significant improvement in HbA1c was seen in the control group.
Abstract: OBJECTIVES: The purpose of this prospective controlled trial was to assess the efficacy of three commercially available glucose products, (1) buccal glucose spray, (2) liquid sugars, and (3) dextrose tablet, on the evolution of plasma glucose concentration (PG). METHODS: Sixteen healthy volunteers aged 21.8 +/- 0.78 y (mean +/- SE), BMI 23.5 +/- 0.84 kg/m(2), tested their PG over the course of 3 sets of 4 sessions (S) each: S(0)-control fasting, S(1)-buccal administration of 10 glucose spray-doses (0.84 g of glucose) without swallowing; S(2-) consumption of 1 sachet (13 ml) of liquid sugar (ca. 5.2 g glucose, 5.2 g fructose, 5.2 g sucrose); S(3-) consumption of one dextrose tablet (6 g). PG was tested in finger-prick capillary blood using a personal glucometer Linus at the start, and at 5, 10, 15, 20 and 30 min. The means of 3 respective sessions for each of the 16 subjects were analyzed. RESULTS: The Wilcoxon signed rank test revealed no significant differences between changes in the mean PG at the start vs. 5-minute interval either in control, or any intervention sessions. Analysis of regression coefficients after 30 min compared to the control session, demonstrated an increase in PG with the sachet of liquid sugars (0.068 mmol/l/min, p = 0.001) which was greater than a single dextrose tablet (0.052 mmol/l/min, p = 0.002), but no significant PG increase was found after buccal glucose spray. CONCLUSION: Liquid sugars or dextrose tablets, but not the buccal glucose spray, are effective means to increase PG within 10 minutes after ingestion.
Abstract: Year: 2008
Abstract Number: 1695-P
Authors: KAROLINA PETERSON, NATALIA LIPPAIOVÃ, RUDOLF CHLUP, MÃRIA PALLAYOVÃ, KATEÅINA LANGOVÃ, Olomouc, Czech Republic, KoÅ¡ice, Slovakia
Institutions: Košice, Slovakia; Olomouc, Czech Republic
Results: The consumption of glucose or foods with high glycemic index (GI) in persons with type 1 diabetes (PWD1) is a hot topic. The aim of this pilot prospective trial was to assess the efficiency of empirically suggested algorithms for premeal insulin boluses in PWD1 using insulin pumps Paradigm X22 with CGMS sensors, Medtronic MiniMed, Northridge, CA. Six PWD1 (aged 46.2 ± 15.09 y, diabetes duration 14.5 ± 9.65 y, HbA1c/IFCC 6.3 ± 1.59%, BMI 23.6 ± 1.67 kg/m2, mean ± SD) were followed for 3 weeks with stable daily nutrients- and energy intake. During the 2nd week, subjects consumed 11 alternative meals in 3 replicates, each containing 50g of carbohydrates (GI>75%: glucose, chocolate rice squares, white bread, honey, ravioli with meat and cheese, mashed potatoes with fish, buttered apricot dumplings, waffles) eaten according to a defined meal plan in order to recalculate their GI. The insulin boluses were adjusted according to tested algorithms (Table 1), hypos (n = 5) were treated by glucose tabs. Individual average glucose levels and daily insulin doses over 3 sequential one-week periods see Table 2. In the whole group, one-week consumption of high GI foods had only a negligeable impact on average glucose levels (9.1 ± 2.33 vs. 9.2 ± 2.30 vs. 9.0 ± 2.43 mmol/l) and daily insulin aspart doses (39.1 ± 8.14 vs. 39.7 ± 10.7 vs. 38.6 ± 9.97 IU/d). So, the suggested algorithms for premeal insulin boluses appear to limit the risk of hyperglycemia resulting from intake of high GI foods.
Table 1. Algorithms for adjustment of insulin boluses (IG - interstitial glucose)[table1]
Table 2. Influence of high GI foods on daily insulin doses and average glucose levels when using the tested algorithms
[table2]
Category: Nutrition - Clinical
Abstract: Year: 2008
Abstract Number: 1978-PO
Authors: RUDOLF CHLUP, HELENA PÅIBYLOVÃ, KAROLINA PETERSON, KATEÅINA LANGOVÃ, VERONIKA MATUÅ KOVÃ, PAVLA KUDLOVÃ, SVATAVA TÃNCOSOVÃ, JIÅà LUŽA, Olomouc, Czech Republic, Moravský Beroun, Czech Republic
Institutions: Moravský Beroun, Czech Republic; Olomouc, Czech Republic
Results: Continuous Glucose Monitoring is becoming a useful tool for diabetes control. However, exact data about patient´s interest in transcutaneous sensors are missing. The aim of this prospective study was to asses the demands for long-lasting use of sensors in persons with diabetes (PWD) on insulin pumps. Forty PWD aged 19 to 83 years, duration of diabetes 1 to 44 years, using insulin pump Paradigm X22 were given a concise 30-min lecture on CGM and offered transcutaneous sensors for a 3-month period free of charge. The education of PWD was performed individually or in small groups by an experienced educator. Several months later the same offer was repeated. The diabetes control at start and end of the study was compared.
Twenty two of 40 PWD (55%) accepted the suggestion and entered the 3-month sensor study. The reasons for a primary sensor refusal (n=18, 45%) were insufficient educational capacity of the center (n=9), lack of time due to occupation (n=5) or family (n=2) and blindness (n=1), nevertheless, 13 of them (33% of 40) would be interested in a short use of sensor (up to one week) without being involved in the study. In the course of 3 study-weeks, 5 persons (12%) interrupted CGM due to technical problems with the transmitter (n=1) or due to personal reasons (n=4); To date, 17 PWD (43%) are using the sensor continuously, all of them are showing interest in long-lasting use in the future.
Hence, the sensors (free of charge) are demanded for long-lasting use by about 43% of PWDs on insulin pumps Paradigm X22. The main reason for the CGM denial was the insufficient educational capacity of the diabetes center.
Category: Clinical Therapeutics/New Technology - Glucose Monitoring and Sensing
Abstract: The aim of this overview notification is to point out the risk factors and causes ofcolorectal carcinoma in diabetics. On the basis of recent information in the literature Type 2 diabetes mellitus has begun to appear as a potential risk factor for colorectal carcinoma. The work focuses on the link between them and outlines a possible solution to this topical issue. When tracking the diabetic population it is recommended that current depistage programmes for colorectal carcinoma be strictly maintained, that dispensing programmes not be neglected, in working with gastroenterologists to share the planning and specific preparation of a diabetic for endoscopy and other interventions and when treating with insulin to give preference to small complementary doses. It is proposed that the dispensing programme for this malignancy be modified for diabetics.
Abstract: BACKGROUND: The glycemic index (GI) is a measure of the ability of a food to raise glucose levels after it is eaten. Continuous glucose monitoring (CGM) has been shown to give identical values of GI when compared to traditional methods. However, there has been no standardized protocol for measuring GI that takes into account interindividual variability and chronophysiological glycemic response to food. Our aim was (1) to create and describe software based on a Microsoft Excel 2000 spreadsheet to facilitate rapid, automated, accurate, and standardized processing of data obtained using recent CGM methodology to measure GI and its variability and (2) to assess the benefits of this new approach. METHOD: Twenty healthy subjects consumed 50 grams of glucose or four alternative foodstuffs (chocolate, apple baby food, rice squares, or yogurt) at breakfast and dinner during 1 week, resulting in 300 CGMS glucose profiles; 92% of meal tests were satisfactory for evaluation. Application and functions of the software DegifXL are described. RESULTS: Using the new spreadsheet software DegifXL, time required for data processing for the 15 data sets for each subject was reduced from 2000 to 160 minutes relative to previously used manual methods. We characterized the GI for four foodstuffs with three replicate measurements in each of 20 subjects and evaluated between person, between time period, and between replicate GI variabilities. CONCLUSION: DegifXL, combined with CGM, was an efficient and effective tool for routine measurement of group- and subject-related GI.
Abstract: Abstract Number: 2083-PO
Authors: RUDOLF CHLUP, KAROLINA PETERSON, JANA ZAPLETALOV[Aacute], KATERINA LANGOV[Aacute], PAVLA KUDLOV[Aacute], HELENA PRIBYLOV[Aacute], VERONIKA MATUsKOV[Aacute], Olomouc, Czech Republic
Results: HbA1c reflects the mean plasma glucose concentration (PG) over the preceding 8 to 10 weeks. PG is closely related to the glucose concentration in interstitial fluid (ISFG). The present study compares the HbA1c with the mean ISFG measured continuously (up to 288 values per day) over the preceding 4-week period. The sensor was inserted into subcutaneous tissue of the gluteal region or abdomen. Signals were transmitted wirelessly into the insulin pump Paradigm 722, Medtronic MiniMed, Northridge. Individual sensors were functioning for 4 to 9 days. Sensor calibration was performed twice daily by means of glucometer Advance, Hypoguard. Six persons with type 1 diabetes (PWD1) aged 47.3 ± 7.97 y (mean ± SE), diabetes duration 22.0 ± 5.10y, treated with insulin aspart administered by means of the pump Paradigm 722 (43.2 ± 5.97 IU/d) were equipped with sensors over 8 weeks (two 4-week periods). Medtronic Minimed Solutions pumps and meters software 7311 v.7.0 was used to download the data from pumps into a PC. Mean ISFG from the first and second 4-week period and HbA1c at start and at the end of each period were analysed by means of the statistical program SPSS v.14.0 (Table 1). Pearsons Correlations were found between HbA1c 2 (day 30) and the mean ISFG1 from the first 4-week period (r = 0.892, p = 0.017) and between HbA1c 3 (day 60) and the mean ISFG2 from the second 4-week period (r = 0.702, p = 0.120). The relation between the difference HbA1c 3 - HbA1c 2 and difference of mean ISFG 2 - mean ISFG 1 was nearly zero (r = -0.199, p = 0.705). Hence, continuous glucose monitoring appears to be helpful in establishing precise relations between the concentration of HbA1c in blood and mean ISFG over several preceding weeks.
Tab. 1: HbA1c and ISFG in PWD1 on Paradigm 722 and sensorParameter HbA1c 1
(Start)
[%] ISFG 1
[mmol/L] HbA1c 2(Day 30)
[%] ISFG 2
[mmol/L] HbA1c 3 (Day 60)
[%]
N 6 6 6 6 6
Minimum 4.7 5.8 4.6 6.0 4.2
Maximum 10.2 16.3 9.3 15.8 8.4
Median 6.5 8.0 5.8 7.8 5.2
Mean 6.8 9.1 6.3 9.1 5.9
Std. Error of Mean (SE) 0.76 1.52 0.71 1.46 0.66
Category: Clinical Therapeutics/New Technology - Glucose Monitoring and Sensing
Abstract: Abstract Number: 2719-PO
Authors: RUDOLF CHLUP, JARMILA REHOROV[Aacute], KATERINA LANGOV[Aacute], JANA ZAPLETALOV[Aacute], PAVLA KUDLOV[Aacute], HELENA PRIBYLOV[Aacute], KAROLINA PETERSON, JOSEF BARTEK, LENKA SLEZ[Aacute]KOV[Aacute], Olomouc, Czech Republic
Results: Foods with low glycemic index (GI) are recommended in a healthy diet. This prospective randomized open-label trial compares the effect of a 2-month consumption of food with low and high GI, respectively, (Table 1) on surrogate markers as BMI, TAG, LDL-CH, HDL-CH and HbA1c. Four test- and one control group, each of 15 healthy persons aged 20 to 50 y were investigated over 4 months: in the 2-month active period (A) all persons in test groups included one of 4 test foods into their daily meal plan and the remaining 3 foods were excluded from their diet; in the course of the previous/sequential 2-month passive period (P) no tested foods were eaten. Other eating habits remained unchanged within both periods in all of the groups. Data were collected at the start and at the end of each period. Differences were calculated by subtracting the values (start minus end). The statistical program SPSS v. 14.0 was used to analyze the results. There was only a little effect of the 2-month consumption of dark chocolate, apple baby food, strawbery flavoured yogurt and puffed rice squares on respective parameters (Table 2) which were at start within normal range. There was no significant difference neither between changes in the active and passive period in four test groups nor in comparison with the control group. Hence, this study has not brought any evidence that foods with low GI should be preferred for a healthy diet.
Table 1: Glycemic index and composition of tested foodsTested food GI
[%] Minimum daily portion
[g] Carbohydrates
[g] Proteins
[g] Fat
[g] Total energy
[kJ]
Dark chocolate 44 92 50 5.9 24.3 1898
Apple baby food 54 278 50 0.6 0.6 883
Puffed rice sqares 77 60 50 4.8 0.7 958
Flavoured yougurt 38 313 50 10.6 6.6 1287
Table 2: Differences in parameters (start - end of active period) in individual groups; mean±SEGroup BMI
[kg/m2] TAG
[mmol/l] LDL-CH
[mmol/l] HDL-CH
[mmol/l] Apo A1
[mmol/l] Apo B
[mmol/l] HbA1c
[%]
Dark chocolate
(n=15) -0.147
±0.212 -0.026
±0.123 -0.079
±0.076 -0.078
±0.047 -0.087
±0.030
p=0.012 0.001
±0.026 0.240
±0.115
Apple baby food
(n=15) -0.031
±0.132 -0.241
±0.092
p=0.020 0.195
±0.141 0.088
±0.148 -0.014
±0.058 0.005
±0.060 -0.006
±0.058
Flavoured yogurt
(n=15) -0.021
0.108 -0.260
±0.145 0.246
±0.098
p=0.025 0.015
±0.058 -0.123
±0.056
p=0.045 0.032
±0.085 0.073
±0.142
Puffed rice squares
(n=15) -0.020
±0.148 -0.178
±0.101 0.181
±0.098 0.079
±0.063 0.014
±0.145 0.051
±0.028 -0.078
±0.134
Category: Nutrition - Clinical
Abstract: Absorption rates of the phosphate-buffered insulin analogs aspart, lispro, and glulisine prevail over that of regular human insulin. The aim of this prospective observational open-label controlled study was to compare the effects of aspart and human regular insulin resulting from their sequential long-lasting routine administration in small preprandial boluses to individuals with type 2 diabetes according to identical algorithms.
Abstract: Abstract Number: 2720-PO
Authors: KAROLINA PETERSON, RUDOLF CHLUP, PAVLA KUDLOV[Aacute], LENKA SLEZ[Aacute]KOV[Aacute], JANA ZAPLETALOV[Aacute], KATERINA LANGOV[Aacute], BLANKA DOUBRAVOV[Aacute], JOSEF BARTEK, PAVEL SECKAR, MARIE NAKL[Aacute]DALOV[Aacute], Olomouc, Czech Republic, Moravsk[yacute] Beroun, Czech Republic
Results: The hyperglycemic power of food is determined by its glycemic index (GI). The purpose of this prospective open-label trial was 1) to compare the GI´s of 4 selected foods in persons with type 2 diabetes (PWD2) treated with B-cell stimulators (BS) and/or metformin (M) with the respective GI´s in healthy persons (HP) (Table 1), 2) to assess the influence of BS/M a) on the GI and b) on the hyperglycemic effect of the mixed meal test (MMT). To determine the GI, portions of tested foods containing 50 g of carbohydrates (CH) and portions of MMT (75 g CH) were eaten for breakfast or for dinner after 10 and 4 h fast, respectively. PG-curves were constructed from 25 glucose values obtained by the CGMSTM, Medtronic-Minimed, within 120 min after the meal in 5-min intervals and from 9 glucometer Advance, Hypoguard, values in 15-min intervals. Each food was tested 3 times within 9 days. In HP´s (n=20) the GI was calculated as the mean from 20 GI´s averaged from Test 1, 2, 3; in PWD2, individual GI´s from Test 1, 2, 3, 4 were compared (Wilcoxon). BS/M were stopped on day 2 and re-started on day 9. Test 4 was performed 6 weeks later and compared to HP (Mann-Whitney). MS Excel, software DegifXL and the statistical program SPSS v. 10.1 were used to analyze the data. There was no significant difference between the GI of respective foods in HP and PWD2 (p > 0.05) except apple baby food. In PWD2, no influence of BS/M on the GI and on the hyperglycemic power of MMT could be statistically demonstrated.
Table 1: Characteristics of PWD2 and HP at baseline (mean±SE; *** p<0.001)Group PWD2 (n = 17) HP (n = 20) Reference range
Age [years] 57.76±2.45 24.4±0.71*** n/a
Duration of diabetes [years] 6.35±0.83 0 n/a
BMI [kg/m2] 32.09±1.08 22.30±0.73 < 25
HbA1c/IFCC [%] 5.57±0.45 2.91±0.05*** 2.1 - 4.0
Total cholesterol [mmol/l] 5.10±0.36 4.45±0.19 < 5
HDL cholesterol [mmol/l] 1.29±0.09 1.7±0.11*** 1 - 1.6
LDL cholesterol
[mmol/l] 2.56±0.25 2.28±0.16 < 2.6
Triacylglycerols
[mmol/l] 2.83±0.54 1.02±0.13*** < 1.7
C-peptide[ug/l] 3.64±0.39 1.4±0.11*** 1.1 - 5.0
Table 2: GI [%] at baseline (Test 1), after withdrawal and restart of BS/M (Test 2-4); mean±SEGroup
Test PWD2
Test 1
(n = 17) PWD2
Test 2
(n = 17) PWD2
Test 3
(n = 17) PWD2
Test 4
(n = 17) HP
Test 1,2,3 (mean)
(n = 20) p<0.05
No of days without BS/M 0-2 2-5 5-8 40-50 days after restart of BS/M n/a
Glucose 100 100 100 100 100
Apple baby food 68.18±15.04 47.94±6.35 92.59±42.91 30.29±6.15 53.8±8.43 Test4 vs HP; Test4 vs 1; Test4 vs 3
Dark chocolate 48.18±6.59 58.94±6.78 55.82±15.46 54.29±12.99 44.0±4.85
Puffed rice squares 91.82±8.52 47.94±6.35 195.47±106.59 82.71±15.72 76.9±6.34
Flavoured yogurt 48.53±5.34 62.47±8.35 77.00±24.24 51.94±8.41 37.7±4.82
Mixed meal test 46.65±13.71 - 103.24±49.68 36.18±6.38 -
Metformin mg/24 h (in 9 PWD2) 500 - 2550 0 0 500 - 2550 0
B-cell stimulators
mg/24 h (in 10 PWD2) glimepirid 2-3/repaglinid 1.5/ gliclazid 30-160 0 0 glimepirid 2-3/repaglinid 1.5/ gliclazid 30-160 0
Category: Nutrition - Clinical
Abstract: Benefits of continuous glucose monitoring transmitted to Paradigm 722
Abstract Number: 2099-PO
Authors: KAROLINA PETERSON, RUDOLF CHLUP, KATERINA LANGOV[Aacute], JANA ZAPLETALOV[Aacute], PAVLA KUDLOV[Aacute], HELENA PRIBYLOV[Aacute], Olomouc, Czech Republic
Results: The recent insulin pump Paradigm 722, Medtronic MiniMed, Northridge, enables daily reading of 288 interstitial fluid glucose concentrations determined by a sensor inserted into subcutaneous tissue; sensor signals are transmitted wirelessly into the insulin pump in 5 min. intervals, enabling the person to see his/her actual glucose concentration on the pump display and adapt further treatment. This study assess the development of HbA1c concentrations in the course of a 2-month period with nearly continuous use of glucose sensors in 6 persons with type 1 diabetes (PWD1) on Paradigm 722 (Table 1). For comparison, HbA1c in 6 PWD1 on Paradigm 712 performing intensive selfmonitoring (3 to 5 times/d) on glucometer Advance, Hypoguard, (Table 2) was evaluated. All previously educated and good compliant PWD1 were on continuous subcutaneous insulin infusion (insulin aspart) for at least 5 previous months. The statistical program SPSS v.14.0 was used to analyze the data. Between both groups, there was no difference in age (p=0.815), in diabetes duration (p=0.441) and in daily insulin dose (p=0.469). In each PWD1, the regression coefficient (r) from 3 values of HbA1c was calculated. In PWD1 on Paradigm 722, the negative r demonstrates the decrease of HbA1c which is not seen in PWD1 on Paradigm 712. Independent samples test revealed difference between regression coefficients obtained from PWD1 on Paradigm 722 and on Paradigm 712 (p=0.003). So, the use of insulin pump Paradigm 722 with continuous glucose monitoring resulted in significant improvement of HbA1c. However, these benefits are limited by increased discomfort for PWD1 due to the necessity of constant care of the sensor and transmitter.
Table 1:HbA1c in the course of 2 months in 6 PWD1 on Paradigm 722 (continuous glucose monitoring)PWD1 Age
[y] Diabetes duration
[y] Insulin
[IU/d] HbA1c 1
[%] HbA1c 2
[%] HbA1c 3
[%] Regression coeficient r
1 56 43 58.2 4.7 4.6 4.2 -0.25
2 31 23 48.0 6.5 6.2 5.1 -0.70
3 18 7 61.2 6.9 7.1 7.4 0.25
4 68 21 26.8 10.2 9.3 8.4 -0.90
5 64 12 32.3 5.7 5 5.1 -0.30
6 47 26 32.7 6.5 5.4 5.2 -0.65
mean
± SE 47.3
± 7.97 22.0
± 5.11 43.2
± 5.97 6.7
± 0.76 6.2
± 0.71 5.9
± 0.66 -0.43
± 0.17
Table 2: HbA1c in the course of 6 months in PWD1on Paradigm 712 (selfmonitoring 3-5 times/d)PWD1 Age
[y] Diabates duration
[y] Insulin
[IU/d] HbA1c 1
[%] HbA1c 2
[%] HbA1c 3
[%] Regression coefficient r
C1 23 21 38.1 11.0 10.8 10.8 0.50
C2 59 35 25.2 6.3 5.9 5.9 0.45
C3 58 14 32.4 6.3 4.8 4.8 0.05
C4 29 20 54.7 6.5 6.0 6.0 0.15
C5 40 7 47.7 5.3 4.7 4.7 0.70
C6 60 1 26.0 3.8 3.6 3.6 0.20
mean
± SE 44.8
± 6.72 16.3
± 4.87 37.4
± 4.84 5.4
± 0.83 6.5
± 0.98 6.1
± 1.00 0.34
± 0.10
Category: Clinical Therapeutics/New Technology - Insulin Delivery Systems
Abstract: The glycaemic index (GI) is a measure of the food power to raise plasma glucose (PG) concentration after a meal. For its determination, classical methods register the development of glucose concentration in capillary plasma or whole blood. The aim of this prospective open-label trial was to compare the GI of selected foods obtained by means of the Continuous Glucose Monitoring System (CGMS) (Minimed Medtronic, Northridge, USA) which has not been applied for this purpose until now, with the respective GI determined by a conventional method using the Glucometer Advance System (GAS) (Hypoguard, Woodbridge, United Kingdom), and to assess the advantages of each approach. METHODS: Portions of tested foods containing 50 g of carbohydrates were eaten for breakfast and for dinner after 10 and 4 h fast, respectively, by 20 healthy volunteers. Using GAS, PG-curves were constructed from 9 PG values at time 0, 15, 30, 45, 60, 75, 90, 105 and 120 min after the meal, and, using CGMS, from 25 values of interstitial fluid glucose concentration (ISFG) stored within 120 min in 5-minute intervals in CGMS memory. The GI was calculated (for GAS and CGMS separately) by dividing the incremental area under the curve for the tested food by the average area of 3 tests performed with the standard. Having excluded tests with missing glucose values, there remained 285 GAS- and 290 CGMS tests for further analysis. In each volunteer, each food was tested 3 times within one week so that 1 to 3 GI's were obtained and averaged. The GI for each tested food was calculated as the mean from the respective average GI's of 20 volunteers. The GI-variability was assessed according to the respective SD. The preference of GAS vs. CGMS in the persons tested was explored by means of a questionnaire. MS Excel and the statistical program SPSS v. 10.1 were used to analyze the data. RESULTS: The GI values (mean +/- SD) measured by GAS/CGMS were for dark chocolate 43.6 +/- 22.13 %/44.0 +/- 21.71 % (p > 0.01); for apple baby food 46.1 +/- 21.38 %/53.8 +/- 37.69 % (p > 0.01); for puffed rice squares 76.5 +/- 20.24 %/76.9 +/- 27.62 % (p > 0.01); for yogurt 43.2 +/- 20.17 %/37.7 +/- 21.55 % (p > 0.01). The GI's of dark chocolate, apple baby food and yogurt, determined by either method, were significantly lower than the GI of puffed rice squares (p < 0.01). CGMS was preferred by 12 of 20 volunteers (60 %). CONCLUSIONS: No significant difference could be seen between the GI's determined by conventional method (GAS) and by CGMS (p > 0.01). The method with CGMS is reliable and comfortable for both tested persons and investigators. Hence, it appears to become a sophisticated approach to determine the GI.
Abstract: BACKGROUND: The sensor of the Continuous Glucose Monitoring System (CGMS, Medtronic Minimed, Northridge, CA) is labeled to expire 6 months following its production and to measure the glucose concentration in interstitial fluid up to 3 days after insertion. The purpose of this study was to demonstrate potential possibilities of sensors when used beyond their expiry date. METHODS: Twenty sensors, each between 3 to 18 months after the expiry date, were assessed in a 7-day period after insertion. Twenty healthy volunteers 23.4 +/- 2.92 (mean +/- SD) years old were trained in handling the CGMS and the Hypoguard (Woodbridge, UK) Advance glucometer system to measure their capillary plasma glucose concentration 18 times a day. Sensor function was estimated according to the number of readings per day, the accuracy according to the mean absolute difference (MAD), and correlation coefficient (r) between glucometer and sensor resulting from paired values. RESULTS: Uninterrupted sensor function was found in 117 of 140 sensor-days (83.6%). A reduction of readings in 23 sensor-days (16.4%) was caused by user error (5 sensor-days, 3.6%), connecting cable (7 sensor-days, 5%), sensor failure (8 sensor-days, 5.7%), or uncertain factors (3 sensor-days, 2.1%). MAD was always < 28%, and r = 0.79. CONCLUSIONS: Neither the expiry date nor the 3-day period of use limits the reliable function of a CGMS sensor. Sensors were found to function as long as 18 months after the expiry date, mostly for at least 7 days. There were no serious local adverse reactions. Prolongation of shelflife label and insertion time appears to be reasonable. Further studies are in progress.
Abstract: Abstract Number: 2562-PO
Authors: RUDOLF CHLUP, PAVLA KUDLOV[Aacute], PAVEL SECKAR, JANA ZAPLETALOV[Aacute], JOSEF BARTEK, KAROLINA CHLUPOV[Aacute], JIR[Iacute] LUZA.
Institutions: Olomouc, Czech Republic; Karlsburg, Germany.
Results: The glycaemic index (GI) is a measure of the food power to raise plasma glucose (PG) concentration after meal. The aim of this prospective open-label trial was to compare the GI of 4 selected foods in 20 healthy persons (HP) and in 20 persons with type 1 diabetes (PWD1) on insulin aspart administered of pumps (Medtronic-Minimed) using their previously optimized algorithms for insulin substitution. Portions of tested foods containing 50 g of carbohydrates were eaten for breakfast and for dinner after 10 and 4 h fast, respectively. PG-curves were constructed from 25 glucose values obtained by means of the Continuous Glucose Monitoring System (CGMSTM), Medtronic-Minimed, within 120 min after the meal in 5-minute intervals. In each person, each food was tested 3 times within 8 days and its GI was calculated as the mean from the averaged GI´s of 20 HP and separately from GI´s of 20 PWD1. MS Excel, software DegifXL and the statistical program SPSS v. 10.1 were used to analyze the data from a total of 251 successful tests. In both HP and PWD1, the GI´s of dark chocolate, apple baby food, yogurt were significantly lower than the GI of puffed rice squares and glucose (p<0.05). In PWD1, GI of yogurt and apple baby food was different (p<0.05). When comparing HP and PWD1, no significant difference was seen between the respective GI´s of tested foods except yogurt (Table 1). Hence, the hyperglycaemic effect appears to be mostly identical.
Table 1: GI of tested foods in HP and in PWD1 (mean ±SE)Food Healthy persons PWD1 p
n 20 20 -
Age [y] 21 - 32 22 - 63 -
BMI [kg/m2) 18.5 - 26.5 18.0 - 29.0 -
Glucose [%] 100 100
Dark chocolate [%] 44.0±4.85 55.4±8.34 0.236
Apple baby food [%] 53.8±8.43 37.9±3.89 0.09
Puffed Rice squares [%] 76.9±6.34 87.9±8.88 0.307
Flavoured Yogurt [%] 37.7±4.82 66.2±8.96 0.007
Category: Nutrition - Clinical
Abstract: Abstract Number: 2051-PO
Authors: RUDOLF CHLUP, JANA ZAPLETALOV[Aacute], PAVEL SECKAR, EVA MAL[Aacute], PAVLA KUDLOV[Aacute], KATERINA LANGOV[Aacute].
Institutions: Olomouc; Moravsk[yacute] Beroun, Czech Republic.
Results: Complementary insulin therapy consists of preprandial boluses of short-acting insulin (1 to 8 units) to cover the failing initial peaks of prandial insulin secretion in persons with type 2 diabetes (PWD2). Absorption rates of phosphate buffered insulin analogs, aspart (ASP), lispro and glulisine, prevail over regular human insulin (R). Aim of this open label prospective study is to compare the effects of ASP and R when both were administered in two sequential periods to educated patients acccording to identical algorithms. Fifty-seven PWD2 aged 64±1.3 (mean±SE) years (y) with diabetes duration 13±1.1 y, treated with insulin for 5.2±0.44 y, serum C-peptide 2.0±0.33 ug/l, entered the study. Following two check-ups performed in the course of the first 364±17.9-day baseline period, R was changed for ASP in similar boluses (p>0.05); then, two check-ups in the course of the second 330±11.1-day period were carried out. Replacement of R with ASP after check-up 2 was the only change in the treatment of diabetes. The DCCT/NGSP scale was used for HbA1c values (reference range 4.2-6.0%). Data were analyzed using the statistical program SPSS v.10.1, incl. paired t test. After the switch from R to ASP, the HbA1c decreased from 8.4±0.23% at check-up 2 to 7.9±0.17% at check-up 3 (p<0.05) and to 7.5±0.20% at check-up 4 (p<0.05), while the baseline insulin dose (37.1±1.4 IU/d), the BMI (30.5±0.82), the individual frequency of selfmonitoring (2.1±0.16/d) and No of hypo- and hyperglycaemias (2.0±0.36 and 47.1±3.81%, resp.) on glucometer Optium, Abbott, did not change (p>0.05). There was no significant difference either in 10-point plasma glucose profiles, heart rate, blood pressure or in biochemical parameters of lipoprotein metabolism, liver and kidney function. Patients´ satisfaction was good. No adverse event was recognized. Hence, for routine complementary insulin treatment in PWD2, ASP appears to be more effective than R.
Category: Clinical Therapeutics/New Technology - Pharmacologic Treatment of Diabetes or its Complications
Abstract: Year: 2005
Abstract Number: 560-P
Authors: RUDOLF CHLUP, DANIELA JELENOV[Aacute], KAROLINA CHLUPOV[Aacute], JANA ZAPLETALOV[Aacute], JOSEF BARTEK
Institutions: Olomouc, Czech Republic
Results: The sensor of the Continuous Glucose Monitoring System (CGMS, Minimed-Medtronic, California) is declared to expire 6 months following its production and to measure the glucose concentration in interstitial fluid up to 3 days after its insertion. In this study, 20 sensors, each to be 3 to 18 months after the expiry date, were assessed for the prolonged function and accuracy in a 7-day period after the insertion. Twenty healthy volunteers (5 groups, 4 volunteers each), aged 23.4±2.92 (mean±SD) years were trained in handling with the CGMS and glucometer Advance (Hypoguard). Sensors were inserted into the subcutaneous tissue of the hip on the day 0 and kept in use up to 8 days. The sensor function was estimated according to the number of sensor results per day, the accuracy according to the mean absolute difference (MAD) between glucometer and sensor. There were no local complications. One sensor died on day 5. There was no difference between the accuracy of sensors 3 and 18 months beyond the expiry date. See Table and Figure for details.
Hence, neither the expiry date nor the recommended 3 day period of use limit the reliable function of a CGMS sensor. Having been properly stored, sensors were found to function as long as 18 months after the expiry date for at least 7 days after their insertion.
Data from CGMS sensor (means)Day No 1 2 3 4 5 6 7
N 287.4 284.8 287.9 287.7 277.2 277.2 252.8
Glucose max 9.9 9.3 10.2 9.4 8.9 10.6 9.5
Glucose min 3.1 3.8 3.7 3.6 3.8 3.9 3.3
Glucose mean±SD 6.1±0.65 6.2±0.41 6.2±0.52 6.2±0.67 6.0±0.58 6.5±0.78 6.2±0.70
No of glucometer-sensor pairs 14.5 15.4 14.6 14.5 14.9 14.8 13.7
MAD±SD 13.3±4.86 13.6±4.15 12.2±2.84 13.4±4.06 14.0±7.40 12.5±4.50 13.8±4.66
Correlation r 0.8 0.6 0.8 0.9 0.7 0.9 0.7
[figure1]
Category: Clinical Therapeutics/New Technology - Pharmacologic Treatment of Diabetes or its Complications
Images:
Abstract Image No. 1
Abstract: The aim of this prospective clinical study was to compare the results of B-glucose estimations performed simultaneously on glucometer Advance (with Micro-draw strips) and Optium (G3 strips) by lay healthy volunteers under non-standardized conditions of everyday life, to assess the difficulties dealing with lay-handling of these systems and to demonstrate the possibilities of the software Glucobalance (Hypoguard) and PC-Link (Medisense/Abbott) for the analysis of selfmonitoring. In the course of 5 days, a total of 721 pairs of measurements were carried out on 10 pairs of glucometer Advance and Optium by 10 healthy volunteers aged 16-40 years. The data transfer of all values into computer from glucometer Advance using the Glucobalance software and from glucometer Optium using the PC-Link was carried out to determine the results. The correlation of B-glucose measured on the glucometer Advance and Optium was strong (r = 0.73). Glucometer Advance brings values about 0.21 +/- 0.06 mmol/l lower than glucometer Optium. The average difference found within each pairs of glucometers Advance - Optium varied. Nevertheless, these differences are acceptable for routine selfmonitoring. The handling of glucometer Advance is not difficult for lay persons. The Glucobalance software simplifies the result evaluation by each tested person. Even though there are some advantages in comparison with the PC-Link, it should be further developed.
Abstract: The metabolic syndrome mostly represented by obesity and hyperinsulinaemia connected with insulin resistance, presents the main mechanism in the pathogenesis of cardiovascular disease. The aim of this study was to analyze the interrelations between several metabolic variables (including leptin) and factors related to insulin resistance in groups of both normal and non-diabetic hyperlipemic postmenopausal women and men of appropriate age, and to attempt to elucidate the gender differences. Two groups of patients (20 men, 20 women) with hypertriglyceridemia were compared with 30 individuals (10 men, 20 women) with normal serum triacylglycerols. Fasting serum leptin concentration, lipid parameters (triacylglycerols, HDL cholesterol, LDL cholesterol) and BMI were measured and compared with changes in insulin parameters influencing insulin resistance (HOMA IR, insulin, intact proinsulin, C-peptide). Statistical analysis was performed using SAS/STAT software including unpaired Student's t-test, Kolmogorov-Smirnov's test, Spearman's rank-order correlation and multiple regression analysis. In men, the insulin sensitivity correlates with leptin only. In women insulin sensitivity is markedly influenced by a complex of factors: leptin and lipid parameters. Increased insulin resistance in men is followed mainly by the increased correlations between leptin, HOMA IR and insulin parameters. In women correlations between leptin, HOMA IR and insulin parameters were smaller, but the inverse correlation with HDL cholesterol was stronger. In postmenopausal women and also in men, serum leptin concentration contributes to insulin resistance. However in women the effect of increase in serum triacylglycerols in contribution of insulin resistance seems to be more dominant.
Abstract: Insulin resistance and obesity are very frequent disorders and are described as the dominant risk factors for cardiovascular disease. The aim of this study was to analyze the interrelations between several metabolic variables (including TNF-alpha) and factors related to insulin resistance in groups of both normal and hyperlipidemic postmenopausal women and men of appropriate age, and to attempt to elucidate the gender differences. The study was carried out on 70 out-patients of the Metabolic Center. From these, 40 patients (20 men and 20 women) were selected with mild hyperlipidemia. Two other groups (10 men and 20 women) with approximately normal serum lipids parameters were taken as "controls". In hyperlipidemic women the mean serum concentration of the TNF-alpha was no different from that in the control group in spite of the fact that values of HOMA IR, insulin, proinsulin and lipid parameters increased significantly. In hyperlipidemic men we have found the decrease in TNF-alpha in comparison with the control group. In all four groups the statistical analysis showed correlations between metabolic parameters (including TNF-alpha) and parameters related to insulin resistance. Also differences in relation to the gender have been found. Multiple regression analysis demonstrated the important role of TNF-alpha in the regulation of both the insulin resistance and in the secretion of insulin in women. In men, BMI and HDL-cholesterol played a dominant role, while the role of TNF-alpha seemed to be minimal.
Abstract: The glycaemic index (GI) is a measure of the food power to raise blood glucose (B-glucose) concentration after a meal. For healthy eating, foods with low GI are recommended. However, for many foods in the European Union the GI has not been defined yet. The aims of this prospective open-label study were: (1) to determine the GI of white bread and juicy cereal bars FIT (Usovsko, Czech Republic) by means of the glucometer Optium (Abbott/Medisense); (2) to compare the GI of tested foods determined in the morning and in the evening hours; (3) to compare the GI of tested foods in men and women and (4) to assess the variability of the GI.
Abstract: Drunkenness and/or hypoglycaemia are possible causes of unusual behavior in a person with diabetes. The aim of this study was to demonstrate different methods which were used in two contradictory reviews of experts for retrospective assessment of a patient's condition in the course of a car crash: An insulin-treated driver caused a car accident resulting in injuries to two men. He was accused of the crime of damage to health as well as of driving under the influence of an addictive drug. One expert, having seen the police and medical reports, concluded the driver was influenced by alcohol at the time of the accident. The contradictory argument of another expert, based on his own thorough investigation including self monitoring and completed by a model experiment, resulted in the conclusion that the driver was probably influenced by hypoglycaemia. Thus, the methods of the second expert seem to be useful reasonable tools to assess the unusual behavior of a person with diabetes.
Abstract: This pilot study deals with the possibilities of a Continuous Glucose Monitoring System (CGMS, Minimed- Medtronic) to optimize insulin substitution. Ten persons with type 1 diabetes mellitus treated by means of an insulin pump entered the study and eight of them completed the protocol. CGMS was introduced for a period of 5 days. The standard dinner (60 g of carbohydrates) and overnight fasting were designed to ensure standard night conditions in all persons in the study while maintaining their usual daily eating routine, physical exercise and assessment of prandial insulin boluses. The only adaptation of basal rates of insulin pump was performed on day 3. Comparison of the mean plasma glucose concentration (0:00-24:00 hrs) between day 2 (before adaptation) and day 4 (following adaptation) was made. An independent comparison of the mean plasma glucose concentration between the night from day 2 till day 3 (22:00-6:00 hrs) and the night from day 4 till day 5 (22:00-6:00 hrs) was performed. The mean plasma glucose investigated by means of CGMS improved in the 24-hour period in 5 out of 8 persons and in the night fasting period (22:00 to 6 hrs) in 6 out of 8 persons. The CGMS is a useful means for assessment of the effectiveness of basal rate and prandial insulin doses in persons with type 1 diabetes treated by means of an insulin pump. However, further studies are necessary to improve the algorithm for insulin substitution.
Abstract: Absorption rates of phosphate buffered insulin analogs aspart and lispro prevail over regular human insulin. However, insulin aspart has not been widely used. The aim of this open controlled clinical study is to compare the metabolic effects of insulin aspart and phosphate buffered insulin when both are used in insulin pumps according to the identical algorithms. METHODS: Twenty one persons aged 39.9 +/- 2.89 (mean +/- SE) years (y) with type 1 diabetes mellitus duration of 17.9 +/- 2.21 y treated by an insulin pump for 4.3 +/- 0.53 y (at least 3 months), educated in self monitoring, entered the study. Mean plasma glucose, rates of hypo- and hyperglycaemias from the glucometer memory and other data from the first 256 +/- 19.97 days period with regular human insulin (check-up 1 and 2) and consequent 364 +/- 8.78 days long period with insulin aspart (check-up 3 and 4) were compared (paired t-test). Replacement of human regular insulin with insulin aspart after two check-ups was the only change in the treatment of diabetes. No special therapeutic education or training was made during the study. RESULTS: In persons with type 1 diabetes treated by an insulin pump with insulin aspart, despite the lower daily dose of insulin aspart vs human regular insulin, the HbA1c decreased; the frequency of hypo- and hyperglycaemias and the BMI did not change. CONCLUSIONS: Insulin analog aspart appears to be more effective for continuous subcutaneous insulin infusion than regular human insulin.
Abstract: Leptin is a circulating pleiotropic hormone that play an important role in appetite control, fat metabolism, regulation of body weight, fetus growth, growth and aging of adults and hematopoiesis. It is expressed abundantly and specifically in the adipose tissue. A liver cell with developed steatosis represents a cell metabolism similar to metabolism of cells of adipose tissue. Analyses of serum leptin and free leptin receptor in the serum of patients with steatosis showed significant variations from reference limits of normal values. However in liver tissue with verified steatosis detection of mRNA gene for leptin was not proven. Such expression of ob gene for leptin was not found even in the liver tissue without steatosis. With respect to the absence of ob gene expression, the direct effect of ob gene expression on other parameters of leptin metabolism could not be evaluated. The RT-PCR method with verified specificity and satisfying sensitivity was developed. The results obtained from analysis of serum leptin and free leptin receptor in the serum are presented and evaluated. The used methods were verified and reference limits for Czech population were defined in dependence on age and other clinical parameters.
Abstract: The core of this review are questions dealing with links between diabetes mellitus and liver diseases. Based on the literature and on their own observations the authors conclude that a liver disease may induce and/or worsen the development of type-2 diabetes mellitus (so called hepatogenic diabetes) and vice versa, a diabetes may result in a liver damage, e.g. simple steatosis or even non-alcoholic-steatohepatitis. The diagnosis of diabetes in hepatopathy is defined according to the same criteria as in patients without any hepatic involvement. The treatment is based on adequate food intake without alcohol and on restricted physical activity. Complementary insulin treatment is recommended whenever the BG-concentrations in a daily profile exceed 10.0 mmol/l. Oral antidiabetic drugs should be used only if they result in a marked improvement of diabetes control and no signs of liver damage appear.
Abstract: The aim of the present study was to evaluate the effects of complementary insulin therapy, consisting of a single dose of 1 to 8 units of shortacting insulin before each meal (4-6x daily) and sometimes at 02.30 h, on concentrations of serum lipids, lipoproteins and apoproteins in type 2 (non-insulin-dependent) diabetic patients, unsatisfactorily controlled either by oral hypoglycemic agents (OHA) or by longacting insulin 1-2x daily (INS 1-2). Compared means +/- SD. Patients on INS 1-2 (n = 82) had better baseline glycemic control than patients on OHA (n = 68) (HbAlc: 9.33 +/- 1.76% vs. 10.59 +/- 1.83%, p < 0.001 and fructosamine: 3.34 +/- 0.74 mmol/l vs. 3.85 +/- 0.84 mmol/l, p < 0.001) and serum triglyceride concentrations (3.03 +/- 2.05 mmol/l vs. 4.95 +/- 4.48 mmol/l, p < 0.001), in spite of longer duration of diabetes (13.35 +/- 8.07 years vs. 10.1 +/- 6.9 years, p < 0.001). After 8-10 weeks of complementary insulin therapy, OHA patients (n = 33) improved both the glycemic control (HbA1c: 10.5 +/- 1.78% vs. 9.0 +/- 1.75%, p < 0.001) and fructosamine: 4.0 +/- 0.85 mmol/l vs. 3.5 +/- 0.76 mmol/l, p < 0.001) and most of the lipid parameters (decreased serum triglyceride: 5.8 +/- 5.64 mmol/l vs. 3.6 +/- 4.69 mmol/l, p < 0.001, total cholesterol/HDL-cholesterol: 6.8 +/- 3.13 vs. 5.6 +/- 2.23, p < 0.01 and increased HDL-cholesterol: 1.0 +/- 0.30 mmol/l vs. 1.2 +/- 0.30 mmol/l, p < 0.001, apo AI: 1.6 +/- 0.26 g/l vs. 1.8 +/- 0.28 g/l, p < 0.001, LpAI particles: 0.6 +/- 0.1 g/l vs. 0.7 +/- 0.12 g/l, p < 0.001 and LDL-cholesterol/apo B: 2.1 +/- 0.67 vs. 2.7 +/- 0.67, p < 0.001). In patients previously on INS 1-2x (n = 34), complementary insulin therapy with reduced dose of insulin per day (49.6 +/- 22.5 U/d vs. 36.6 +/- 13.3 U/d, p < 0.001) did not further improve glycemic control but improved the number of proatherogenic and antiatherogenic lipoprotein particles (decreased apo B: 1.7 +/- 0.52 g/l vs. 1.5 +/- 0.94 g/l, p < 0.01, apo AI/Lp AI: 2.9 +/- 1.01 vs. 2.3 +/- 0.98, p < 0.01 and increased Lp AI particles: 0.6 +/- 0.10 g/l vs. 0.7 +/- 0.12 g/l, p < 0.0001); BMI also decreased (29.4 +/- 4.28 kg/m2 vs. 28.9 +/- 4.24 kg/m2, p < 0.05). These results demonstrate that complementary insulin therapy probably induces antiatherogenic lipoprotein changes in NIDDM patients previously treated by either OHA or INS 1-2x. Thus, this type of therapy should be used more often and start earlier, and should be preferred to longacting insulins.
Abstract: A kinetic model of oGTT has been used. This model is characterized by 7 glycaemia collections (0, 30, 45, 60, 120, 180 min). In some cases this is supplemented by determination of C-peptide and insulin values (0, 60, 120 min). This method is very simple and highly useful in clinical practice because it gives information about physiological stimulation by enterohormones, the first glucose passage through liver and next glucose utilization. The first part of the study deals with random error of the kinetic model of oGTT found by repeated calculations (> 10,000 repeatings) of identical initial glycaemias in individual groups (DM, PGT, N). Random error of glucose clearance (the most suitable parameter) ranged within 0.2 -2.1% in individual deviations. Then the identical calculations were made but loaded with glycaemia and with certain error in individual collection intervals (glycaemia 0.1, 0.2, 0.5 mmol/l; collection with 30, 60, 300 s). Random error of the method increased significantly with dispersion variance of glycaemias (maximum 17% with glucose clearance at glycaemia dispersion variance of 0.5 mmol/l); changed time intervals less affected random error quantity. As acceptable and frequent deviation in practice was determined glycaemia dispersion variance of 0.2 mmol/l (corresponding to a total analytical error of glycaemia measurement) and dispersion variance of time intervals of 60 s. At these values, random error of the method increased maximally to 10.3%. Glucose has also a biological variability (not published yet for individual time intervals), the value of random error may be higher but will not achieve half of values of random error obtained at the classical oGTT. The second part of the study deals with comparison of both the tests (classical oGTT, kinetic curve of oGTT) in 126 probands examined at metabolic and diabetologic out-patient department of the Hospital in Sternberk. It can be concluded that using a classical oGTT, 60% of patients were classified into incorrect groups as defined by dynamic results obtained by analysis of the kinetic model. Interesting enough is the fact that almost half of persons who cannot be classified by the classical oGTT had impaired glucose tolerance. Out of them, 15.6% had diabetes mellitus; almost 20% of normal patients also had impaired glucose tolerance. Over 1/5 of persons with impaired tolerance for glucose according to the classical oGTT was found by the kinetic model to have diabetes mellitus. On the contrary, 1/10 of diabetic patients diagnosed by oGTT had normal glucose clearance, over 1/2 of patients had only impaired glucose tolerance. Then in 126 persons random error of the method was again calculated (> 2,000 repeated calculations for each proband) amounting 6.6%.
Abstract: Aim of the present prospective study was to assess the potential benefits of complementary insulin therapy, consisting of a single dose of 1 to 8 units of shortacting insulin before each meal, on blood glucose, serum lipid parameters and on patient's well-being. A group of 251 type 2 (non-insulin-dependent) diabetic patients completed the study. The complementary insulin therapy was introduced in hospital in the course of one week. Number of injections per day was increased, the average dose of insulin per day and the average dose of glibenclamide decreased, amount of carbohydrates in food (adapted by patients themselves) diminished, mean blood glucose, number of hyperglycaemia's and number of hypoglycaemia's decreased. At a check-up 8 to 10 weeks later, a decrease of haemoglobin A1c, glycated proteins in serum and body mass index together with improved patient's well-being have been shown. These results demonstrate a good effectiveness of complementary insulin therapy in type 2 (non-insulin-dependent) diabetic patients. We assume this kind of therapy should be more often recommended.
Abstract: 1292
NIGHT INJECTIONS OF REGULAR INSULIN IMPROVE DIABETES CONTROL IN C-PEPTIDE NEGATIVE PATIENTS.
R. Chlup, R. Menzel, H. Keilacker, P. Heinke and E. Jutzi, Ilnd Dept. of Medicine, Palacky University and Hospital Olomouc, Czech Republic
The main aim of the present randomized over-cross study was to compare the short-term effects of two intensive insulin regimens differing just in
overnight therapy: 1.(R) = regular insulin at 10 p.m. and at 2.30 a.m.; 2.(L) = long acting (Ultratard HM) at 5.30 p.m. During day, preprandial boluses
were adapted according to selfmonitoring in both regimens. Doses of Ultratard HM were calculated individually. Thirty five type I (insulindependent)
diabetic men (aged 19-41 years, diabetes duration 3-26 years) were randomized (odd numbers started with regimen R) and treated with
each regimen for 2 weeks. At the end of each test-period blood glucose (BG) and free insulin (FIRI) profiles (16 estimations/d) and insulin dose/kg
body mass/d (INS) were registered. In the whole group the mean BG (MEG) and the INS was lower with the R than with the L (7.78±0.323 vs.
9.05±0.375 mmol/l and 673±27 vs. 763±29 mU/kg body mass/d). There was no difference in FIRI-medians between both regimens (0.189±0.011 vs
0.212±0.013 nmol/1, p>0.05), however, the FIRI at 19.00 h, 20.00 h and 22.00 h was higher with the L and at 5.00 h with the R. In 25 patients the
regimen R resulted in lower MBG than the L (6.88±0,413 vs 9.85±0.381 mmol/l, p<0.o1) even though the INS here was also lower (0.67±0.033 vs
0.800±0.052 u/kg/d, p<0.01). In 10 patients the R resulted in higher MBG than the L (9.19±0.704 vs 6.99±0.489 mmol/l, p<0.05), however, under the
R less insulin (0.667±U.052 vs 0.744±0.055 u/kg/d) was injected in this group. Conclusion: night injections of regular insulin result in better
diabetes control than Ultratard HM in 71 percent of estimations. The lower insulin dose in the R shows better efficacy of this regimen.
Abstract: The purpose of the present cross-sectional clinical study was to evaluate the prevalence of retinopathy in Type 1 diabetic patients without nephropathy and with different degrees of nephropathy. In addition we investigated the association between retinopathy, nephropathy, and other variables, and studied the importance of cardiovascular autonomic dysfunction to these conditions. 76 Type 1 diabetic patients were investigated. All patients were initially selected on the basis of body weight, and 47 proteinuric patients were further selected for age, diabetes duration and the duration of insulin treatment (see Table 1). Proteinuric diabetic patients were categorized by degree of nephropathy, i.e. for incipient nephropathy (proteinuria of less than 0.5 g/day), for overt nephropathy (proteinuria of more than 0.5 g/day), and for renal failure (serum creatinine of more than 103 mumol/l). Retinopathy was assessed by ophthalmoscopy. Cardiovascular autonomic dysfunction (CAD) was assessed by heart rate variations, 30:15 ratios, the Valsalva maneuver, and systolic blood pressure fall upon standing. Our findings revealed increased prevalence of retinopathy in patients with more advanced stages of nephropathy. CAD abnormalities exhibited increased prevalence among proteinuric patients. Our data clearly revealed differences between proteinuric and non-proteinuric patients. In both proteinuric and non-proteinuric patients there were found correlations of retinopathy with diabetes duration, and only in proteinurics was retinopathy correlated with kidney function, systolic blood pressure and CAD findings. In patients in identical stages of nephropathy, increased prevalence of CAD abnormalities was shown in patients suffering from proliferative retinopathy. Thus our data suggest that CAD abnormalities might be related in some way to both the proliferative retinopathy and to diabetic nephropathy.
Abstract: The aim of the present study was to evaluate the potential hazards of multiple use of disposable syringes and needles for insulin injections over a long period of time. A special syringe container (pen-case) was developed to carry the syringe with insulin. In the microbial trial 24 patients, each injecting insulin for 1 week with one disposable needle, were studied for 201 patient-weeks with 5829 injections. Cultures of 154 needles, 155 syringe rinses, 154 pen-case rinses and the remains of insulin in 201 vials revealed no relevant contamination. In the clinical trial 100 diabetic patients were followed up for up to 7 years. Each syringe was reused for 1 to 12 weeks and each needle for 1 to 40 days (4 to 200 injections). Only sporadic redness not exceeding 4 mm2 was seen at sites of about 560,000 insulin injections. Thus, the repeated use of syringes and needles in one diabetic patient may be recommended as a convenient and safe approach in insulin administration.
Abstract: Two types of insulin pens MADI and MD, were connected to subcutaneous catheters. These "catheter-pens" were used like hand-driven insulin pumps. Results after 1 year of treatment in 30 type 1 diabetics (HCP-negative; age at onset of diabetes 16.5 +/- 1.7 years; duration of diabetes 18.5 +/- 1.6 years, on multiple insulin injections before catheter-pen application): 1. better quality of life (reduction of frequency of needle pricks, more flexibility, inconspicuous application of insulin in public); 2. daily insulin--increased number of "injections" (4.2 +/- 0.1 vs 5.8 +/- 0.1, p less than 0.01), reduction of units per kg BW (0.70 +/- 0.02 vs 0.60 +/- 0.01, p less than 0.01), reduction of intermediate-acting insulin (14.1 +/- 1.3 vs 9.2 +/- 1.2 U/d, p less than 0.05); 3. no change of HbA1 (10.8 +/- 0.8 vs 10.2 +/- 0.2%, normal range 7.7 to 8.4%), mean blood glucose (MBG) in stress situation (8.4 +/- 0.4 vs 7.7 +/- 0.3 mmol/l), serum cholesterol and body weight, both within normal range; 4. improvement (p less than 0.05) of serum triglycerides, serum HDL-cholesterol, ratio of apolipoprotein A1/B; 5. rare skin reactions at the needle site. Conclusion. Catheter-pens offer a very convenient alternative for insulin administration in intensified conventional insulin treatment with multiple injections in type 1 diabetics.
Abstract: In Type I-diabetics metabolic response to exercise is largely determined by the availability of exogenous insulin. The aim of the present study was to assess the metabolic response to moderate exercise of 24 insulin-dependent (Type I-) diabetics treated by multiple subcutaneous injections of short acting insulin. Differences in insulin availability (hypo- [trial A] or hyperinsulinemia [trial B]) resulted from the different periods of time that had elapsed since the previous insulin injection, i.e., after 3 hours (trial A), and 1 hour (trial B). Bicycle ergometer tests at intensities up to 75% VO2max, were carried out with patients and controls. Plasma glucose, FFA, glycerol, alanine, growth hormone and glucagon levels were measured during a period of 85 min. In both trials, physical exertion did not have a significant statistical effect on the glucose concentration in the blood of hypo- and hyperinsulinemics. Surprisingly, despite the different insulin availabilities FFA, glycerol, alanine and glucagon concentrations were not statistically different in either trial and appear similar to those of healthy controls. A normal metabolic response to exercise can thus also be expected in Type I-diabetics, provided adequate insulin is available. When compared to controls, growth hormone concentrations were found to have increased during exercise. These experimental data strongly suggest the great necessity of adequate insulin availability in order to obtain normal metabolic responses to exercise in insulin-dependent diabetics. Despite certain degrees of hypo- or hyperinsulinemia, moderate exercise did not cause any marked metabolic derangements. This type of moderate exercise is therefore recommended for improving metabolic control in such patients.
Abstract: The present study focussed on the impact of heavy muscular work upon metabolic homeostasis in insulin dependent (type I) diabetics in situations involving a certain degree of hyper- and hypoinsulinemia. 20 juvenile type I-diabetics were compared with 6 nondiabetic healthy subjects. The diabetics were studied in states of hypo-(trial A) and hyperinsulinemia (trial B) at the start of the exercise. Differences in insulin availability resulted from the different times that had elapsed from the last insulin injection (3 hours in trial A and 1 hour in trial B) before the ergometer test started at 7 a.m. Six diabetics out of 20 patients were studied in both trials A and B to establish the reproducibility of metabolic reactions to the exercise. Bicycle ergometer tests were carried out in the upright position at 5 graded steps of 50 W, 75 W, 100 W, 125 W and a load near to exhaustion. Rest periods of five minutes were allowed between these work periods for taking blood samples before and after each work load. Plasma glucose, FFA, glycerol, lactate, alanine, IRI and HCP concentrations were investigated. The blood pressure at rest and during exercise was measured, and the physical working capacity (PWC170) was calculated according to Wahlund on the basis of the heart rate response to exercise. The results of the exercise tests reflect clearly the different metabolic reactions to heavy muscular work despite the relatively slight differences in insulin availability at the start: --Exhausting muscular work during the hypoinsulinemic state resulted in hyperglycemia and exaggerated lipolysis. --Heavy muscular work in a hyperinsulinemic state resulted in a reduced blood glucose level and antilipolytic reactions in comparison to nondiabetics. These findings suggest the great necessity of an adequate insulin availability during heavy muscular work in juvenile type I-diabetics.
